MXPA06012460A

MXPA06012460A - Apparatus and method for surgical enhancement of aqueous humor drainage.

Info

Publication number: MXPA06012460A
Application number: MXPA06012460A
Authority: MX
Inventors: Michael Hee; David J Kupiecki; John Mckenzie; Ronald Yamamoto; Stanley R Conston
Original assignee: Iscience Surgical Corp
Priority date: 2004-04-29
Filing date: 2005-04-29
Publication date: 2007-07-13
Also published as: JP2012196481A; US20090043321A1; EP1740239A4; CN1976732A; ZA200609408B; AU2005240123B2; CA2564806A1; EP2468327A1; WO2005107664A2; EP2471563A1; JP2007535386A; WO2005107664A3; BRPI0510433A; EP1740239A2; KR20070033974A; NO20065505L; AU2005240123A1

Abstract

An apparatus is provided for forming a tissue tract (8, 11A, 17A) from within a first passageway of an eye (11, 17) connecting to a second passageway in the eye (12, 16) comprising an elongated tool with a proximal end and distal end. The tool has an outer diameter in the range of about 50 to about 1000 microns. Methods of using the tool are provided for creating a fluid path for aqueous humor of an eye from a first passageway of the eye, such as the Schlemm's Canal, to a second passageway, such as the suprachoroidal space.

Description

* METHOD AND APPARATUS FOR SURGICAL IMPROVEMENT OF DRAINAGE OF HUMOR AQUEOUS Field and Background of the Invention 5 Glaucoma is a condition of eye disease in which increased intraocular pressure (IOP) is created by dysfunction in the drainage mechanism for aqueous humor. Aqueous humor occurs within the eye in the ciliary body and flows into the anterior region of the eye. 10 Normally humor drains mainly through a network of tissues in the inner angle of the anterior chamber, called the trabecular meshwork and subsequently to a circular drainage space called the Schle Canal. The aqueous humor continues its drainage route in the collector channels 5 and finally in the aqueous veins to enter the venous system. This route for aqueous humor drainage is often called the trabeculo-canalicular route. The aqueous humor is also drained through a more diffuse secondary route through the sclerotic tissues, 20 mainly from the suprachoroidal space and along the vascular muscles and vessels of the eye. This route for draining aqueous humor is often called the uveal-sclera pathway and is believed to be responsible for 5 to 25% of the total drainage of aqueous humor from the human eye. 25 Typically in glaucoma, the main route for aqueous humor becomes narrowed or occluded, increasing the IOP and resulting in gradual damage to nerves and loss of vision. These conditions are usually treated as topical drugs in the form of eye drops, but can result in surgical treatment if drug treatment becomes ineffective or if patient compliance is a concern. Traditional glaucoma surgery, such as trabeculotomy or trabeculectomy, involves the dissection of the eye and the dissection of a new flow passage through the trabecular meshwork in the anterior chamber. The fluid is channeled to a reservoir formed under the conjunctiva known as a vesicle. While the vesicles are effective in the removal of aqueous humor, the vesicles present a high incidence of post-surgical complications due to irritation and infection. There is also a new class of surgical procedures that propose the treatment of the ocular drainage system from the sclerotic tissues without penetrating the inner chamber of the eye. These procedures are called "non-penetrating" surgery and involve careful surgical dissection of the sclera. Deep scleroty is a form of this procedure in which a portion of the intrascleral tissue is removed near Descemet's membrane to allow significant aqueous flow. Viscocanalostomy is another non-penetrating procedure in the which is dissected the sclera to open the Schlemm Canal in an intra-sclerotic lake. Although non-penetrating procedures present few direct complications compared to traditional surgeries, most procedures require extensive manual dissection of ocular tissues and frequently the subsequent formation of a subconjunctival vesicle in order to provide an alternate drainage route for the fluid. aqueous. The present invention describes microsurgical tools and methods, which allow the surgical creation of a tissue tract within the tissues of the eye to directly connect the Schlemm Canal to the suprachoroidal space, thereby forming a connection between the primary and secondary routes for drainage of aqueous humor. By directing the flow of aqueous humor from the primary drainage route to the uveal-sclera route, restrictions on the primary route downstream of the Schlemm Canal or resistance due to increased episcleral venous pressure can be avoided. The tissue tract can also connect the anterior chamber to the suprachoroidal space to further derive the transverse mesh and Schlemm's canal. Since the aqueous humor goes directly to the secondary drainage route, the creation of a vesicle is not required, eliminating post-surgical complications associated with a vesicle. Additionally, the invention describes devices and materials that can be implemented in the tract to maintain tissue space and fluid flow during the wound healing process. The tools and methods of the invention are designed for minimally invasive surgical use to minimize trauma and to facilitate repeated treatment.

Brief Description of the Invention An apparatus is provided for forming a tissue tract from within a first passage of an eye that connects to a second passage in the eye comprising an elongated tool with a proximal end and a distal end, the tool that it has an outside diameter in the range of about 50 to about 1000 microns. The tool may comprise a flexible microcannula that may be located proximal to the distal end. The microcannula can have a rounded traumatic distant term and a lubricious outer surface coating. The tool may comprise an outer sheath and an inner member. Preferably, the outer sheath is flexible and the inner member has a greater bending stiffness than the outer sheath. The inner member can be removed and changed with another inner member while using the device in the eye.

The tool may comprise a mechanical cutting tip, and / or have the ability to direct tissue ablative energy to the distant end. The distant end may be visible by medical imaging techniques or have a visible beacon by direct observation. The apparatus may further comprise a space maintenance material, or implant, for placement within the tract. The material may comprise an anti-fibrotic agent and / or anti-thrombotic agent. The implant can be a tube or stent-like device and can be made capable of changing configurations when it is distributed in the eye. The implant maintains the space of the tissue tract and provides a route for the flow of aqueous humor through the tissue tract. The implant may comprise microspheres, microparticles, microfibers, open or closed cell matrices, foam or gel. The implant may comprise a suture, a border, or a growth surface inward of the tissue to provide tissue fixation in the tract. The implant can be made of a permanent material such as stainless steel, titanium, titanium alloy, chromium and cobalt alloy, ceramic, carbon or polymeric material; or of a biodegradable or bioerodible material. Methods are provided for using the apparatus to creating a fluid path for aqueous humor of an eye from a first passage of the eye, such as the Schlemm's Canal, to a second passage, such as the suprachoroidal space, the method comprising: a) inserting a microsurgical tool from a site of surgical access in the first route; b) advancing the tool along the first passage to a desired site for the formation of a tissue tract for the fluid path; c) driving the tool to form the tissue tract from the first passage to the second passage; d) remove the tool, and e) close the surgical access site. Advancement of the tool and the drive can be performed a plurality of times to form multiple tracts of tissue from the first passage to the second passage using a single surgical access site.

Detailed Description of the Invention It has been found that Schlemm's Canal and the anterior border of the suprachoroidal space are at similar depths from the sclera surface. The spatial relationship between the two passages has been found to allow the natural geometry of the first passage where the surgical tool is initially inserted to align the tool to create a tissue tract to cross the target passage. In this way, it has been found that a tool can be placed in the first passage from a surgical access site and the tissue tract formed near the surgical access site. Alternatively, the tissue tract may be formed after the advancement of the microsurgical tool along the first passage. It has been found that a tool that is advanced in the first passage by at least a short distance has a natural alignment with the second passage, allowing tissue tracts to be formed without direct visualization at sites remote from the surgical access site. To have access to these passages and to create the tissue tract, the tool will have an outer diameter in the range of about 50 to about 1000 microns. With reference to Figure 1, the relevant anatomical structures of the eye are shown. Cornea 1, anterior chamber IA, sclera 2, iris 3, lens 4 and the ciliary body / choroid 5 are shown. The Schlemm Canal 6 and the suprachoroidal space 7 are shown connected by a tract 8 of tissue prepared in accordance with the invention. The invention provides apparatus, components thereof and related methods to surgically create a drainage tract for aqueous humor that connects the suprachoroidal space to the Schlemm Canal. Both the space Suprachoroidal as the Schlemm Canal are passages for drainage of aqueous humor. In general, methods are provided to surgically access one or both of the passages and to form a tissue tract to connect the two passages. Specifically, the invention comprises the steps of: a) inserting a microsurgical tool from a surgical access site in the first passage; b) advancing the tool along the first passage to a desired site for formation of a tissue tract for the fluid path; c) driving the tool to form the tissue tract from the first passage to the second passage; d) remove the tool, and e) close the surgical access site. Specifically in one modality, the Schlemm Canal is accessed through a surgical flap, small incision, or by penetration of a surgical tool. One or more surgical tools are then inserted into the canal and advanced to create a tissue tract to the suprachoroidal space. Then, optionally, an implant or material can be inserted to maintain the opening of the tract and the fluid flow. Finally, after the tools are removed, the surgical access site is closed as required.

In an alternative embodiment, the procedure may be performed in an inverted manner by first accessing the suprachoroidal space of a living subject through a small incision or by penetration by a surgical tool, second by inserting one or more microsurgical tools into the space suprachoroidal and by advancing one or more tools to create a tissue tract that connects to the Schlemm's Canal, third to optionally insert an implant or material to maintain the fluid flow channel opening, and finally close the surgical access site as is required . An alternative approach comprises the steps of, first performing a surgical flap cut to expose both the Schlemm's Canal and a portion of the suprachoroidal space, create a tissue tract that connects the Schlemm's Canal and the suprachoroidal space, insert an implant or material to maintain the tract opening and fluid flow, and finally close the surgical access site as required. The invention provides an apparatus for creating a tissue tract within eye tissues such that the tract acts as a fluid path from the Schlemm's Canal to the suprachoroidal space along with elements to be implanted in the tract to maintain the fluid flow path . Preferred devices are microcatheter tools flexible that can be advanced along the circumference of either the Schlemm's Canal or the suprachoroidal space to allow minimally invasive surgery to allow the formation of multiple tracts of tissue for drainage from a single tissue access site. To practice the methods of the invention, either the Schlemm Canal or the suprachoroidal space are accessed from the sclera surface. Both regions of tissue are below the sclera, varying in location from patient to patient in relation to the markings on the surface of the eye. Both the Schlemm Canal and the suprachoroidal space can be identified by surgical dissection or high resolution medical imaging methods such as high frequency ultrasound (HFU) or optical coherence topography (OCT). The use of medical imaging may be ideal since more surgically preferred access sites may be selected to minimize trauma and to allow the use of minimally invasive surgical methods. The use of an optical or ultrasound contrast agent, either distributed directly to the Schlemm's Canal, the suprachoroidal space or systemically to the subject, can facilitate identification. The pressure changes applied to the anterior chamber can also facilitate the identification of selection of a preferred surgical access site.

The use of HFU or OCT is also desired to determine the optimal tissue tract placement. The surgeon can use imaging techniques to pre-plan the surgical route and to verify the locations, direction and placement of tools and devices during the procedure. As an example, the surgeon can first access the Schlemm Canal and then create a tract to and in the suprachoroidal space. Alternatively, the method may comprise access from the suprachoroidal space first and then through the tissues of the eye to either the Schlemm's Canal or the anterior chamber. The microsurgical tool may comprise an elongated tool with a distant tip that is directed first to either the Schlemm Canal or the suprachoroidal space. The tool may comprise a mechanical cutting tip such as a solid or hollow trocar member capable of creating a tunnel tract of controlled diameter through the tissues of the eye. In an alternative embodiment, the tool may comprise a means for direct dissection, viscoelastic dissection or tissue penetration to form the tissue tract. In another embodiment, the tool may comprise a hollow tube with a sharp tapered edge used to hollow a tissue tract. The removal or ablation of tissue to form the tract may help maintain the tract and the subsequent placement of an implant or material to maintain space in the canal. Alternatively, the tool may comprise a flexible outer sheath and inner member with the outer sheath positioned axially around the inner member. The inner member may comprise a trocar, solid rod, hollow rod or cylinder, needle, wire or optical fiber. This optical fiber can be used to transport visible light to the tip of the fiber, which can be placed to reside in the tip of the sleeve and can therefore be used for direct visualization of the location of the tool through weaving. sclerotics. In the case of an opaque outer sheath material, a cutting section or window may be provided near the distal tip of the sheath to visualize the fiber optic tip. The optical beacon described can provide an auxiliary method to guide the creation of the tract. Alternatively, the optical fiber can be used to transport energy for ablation of tissue, such as laser energy, in order to create the tract. The tip can also accommodate a source of thermal or radiofrequency energy to remove the tissue. The microsurgical tool is made of a size for access in the Schlemm Canal and space suprachoroidal and to create tissue tracts of controlled diameter. Useful diameters of 50-1000 microns are useful, and diameters of 100-500 microns in particular are preferred for access to the Schlemm Canal. The outer diameter of a sheath member may correspond to these ranges and may comprise a wall thickness between 10 and 100 microns. The microsurgical tool can act as a flexible microcatheter or microcatheter to allow the distant tip to advance into the Schlemm's Canal or the suprachoroidal space before the formation of the tissue tract. By forming the tissue tract away from the surgical access site, the stimulation of wound healing and scarring at the surgical access site will not interfere with the opening of the tissue tract. Typically, the Schlemm's Canal and the suprachoroidal space are surgically accessed with an incision of one to three millimeters around the circumference of the eye. To move a quarter the circumference or 3 clock hours of the eye from the surgical access site, the microsurgical tool will be advanced approximately a minimum of 5 millimeters, thus allowing the tissue tract to form significantly distant from the site of surgical access. A rigid tool with the appropriate shape such as curvature to correspond to the curvature of the tissue passage, will allow 5 millimeters of advancement within the first tissue passage. If a flexible microsurgical tool is used, the length of a flexible tool is preferred to be long enough to create cannulation of at least half the circumference of the Schlemm Canal or the suprachoroidal space, approximately 22 to 40 mm. Flexible tools of this length allow the entire circumference of an eye to be treated at multiple sites from a single surgical access point. In one embodiment, the microsurgical tool comprises a flexible outer sheath and an inner member with greater flexural rigidity than the outer sheath. The tool is inserted through a surgical access site in a first passage of the eye, such as the Schlemm Canal or the suprachoroidal space. The inner member is removed or removed from the distal tip of the tool to allow traumatic advancement of the outer sheath within the passage. After advancing the tip of the tool to a location remote from the surgical access site, the inner member is advanced within the outer sleeve to the distant tip. This can be the same or different inner member, since the inner member can be removed and changed with another during use. Tool mounting now more rigid can be use to advance to a second passage of the eye, such as the Schlemm's Canal, the suprachoroidal space or the anterior chamber. The anterior member can also accommodate cutting tissue abrasion components to facilitate the formation of a tissue tract at the distal tip of the tool as described above. The microsurgical tool may also incorporate features to assist atraumatic advancement within a tissue path such as a rounded traumatic tip or a lubricious outer lining. By creating the tissue tract with a microsurgical tool placed in the Schlemm Canal, the tract can be oriented radially outward from within the canal into the suprachoroidal space. This approach will form the shortest length of the tract to connect the two passages. A tool advanced in the channel in this embodiment will preferably have a flexible tip so that it can be directed to form the tissue tract radially outward, orthogonal to the long axis of the tool. Alternatively, the tissue tract may be formed by advancing the tool tangentially from within the channel to cross the suprachoroidal space. A tool used in this way will have the component of abrasion or cutting of tissue to form the tract at the distant tip of the tool in a forward feed direction aligned with the long axis of the tool. With reference to Figure 2, a diagram of a tissue tract 11A formed from the Schlemm's Channel 11 to the suprachoroidal space 12 is shown. The microsurgical tool 13 is inserted into the channel 11 to create the tract. The cornea 9 and sclera 10 are also shown. To exemplify a method for surgically creating a tissue tract for aqueous flow in the eye, the surgeon will have access to the Schlemm's Canal and place a microsurgical tool into the canal. The microsurgical tool will comprise a sheath and trocar where the trocar has a distant tip configured to form a tissue tract. The tool is advanced within the channel to a desired location for the creation of a tissue tract. The tool is driven to form the tissue tract that connects the suprachoroidal space. A stent-like device attached to the tool is released to maintain the opening of the tract. The tool is removed and the surgical access site is then sealed by any necessary method. With reference to Figure 4A-B, another microsurgical tool that can be used according to the invention is shown. The tool has a Luer connector 19, flexible shaft 20 and an atraumatic tip 21 for the advance through the tissue. The distal end of the tool accommodates a stent 22 secured to the tool. After formation of the tissue tract as described above, the stent is released into the tract where it remains as an independent, distributed stent-graft 23 in Figure 4B. When creating a tract with a microsurgical tool placed first in the suprachoroidal space to form a tissue tract to connect to the Schlemm Canal, the tract is oriented radially in an inward direction. A tool aligned parallel with the equator of the eye having a flexible tip that allows tract formation in a direction orthogonal to the long axis of the tool can be used. Alternatively, the tool can be aligned in the suprachoroidal space at least partially directed towards the Schlemm's Channel and the tissue tract formed by the forward advance of the tool. In an alternative modality, the microsurgical tool can be advanced from the suprachoroidal space to the Schlemm's Canal, and continue advancing until the tissue tract connects the suprachoroidal space to the anterior chamber. The tract may pass through the Schlemm Canal or may alternatively pass through the cornial sclerotic junction before entering the anterior chamber. To increase to maximum aqueous discharge for the treatment of glaucoma, it may be advantageous in some patients to use this modality to form a fluid route from the anterior chamber to the Schlemm Canal and the suprachoroidal space. As an example, the suprachoroidal space is accessed surgically and a tool is placed within the space. A microsurgical tool comprising a sheath and trocar is used, wherein the trocar has a distal tip configured to form a tissue tract. The tool is advanced into the suprachoroidal space within a desired location for the creation of a tissue tract. The tool is driven to form the tissue tract that connects to the Schlemm Canal. A stent-like device attached to the tool is released to maintain the opening of the tract. The tool is removed and the access site is then sealed by any necessary method. In another example, the suprachoroidal space is accessed surgically and a tool is placed within the space. A microsurgical tool comprising a sheath and trocar is used, wherein the trocar has a distal tip configured to form a tissue tract. The tool is advanced within the suprachoroidal space to a desired location for the creation of a tissue tract. The tool is activated to form the tract of. Weave that connects to the anterior chamber either through the Schlemm Canal or in the region of the cornial-sclera junction. A stent-like device attached to the tool is released to maintain the opening of the tract. The tool is removed and then the access site is sealed by any necessary method. With reference to Figure 3, a diagram of a 17A tract of tissue connecting the suprachoroidal space 17 to the Schlemm Channel 16 is shown. The microsurgical tool 18 is inserted into the suprachoroidal space 17 to create the tract. The cornea 14 and the sclera 15 are also shown. The microsurgical tool should preferably adjust the characteristics to allow the orientation of the tract to be identified and controlled by the surgeon. The use of known medical imaging systems to coordinate or verify the position and orientation of the tract will aid in the accuracy and precision of the tract placement. The imaging system should allow the identification of the target tissue and the position of the tool while minimizing the creation of artifacts in the image. The selection of material and the use of contrast markers known in the imaging technique can be used to provide the desired properties of formation of images for tools. As described above, the tract can optionally be filled with an implant to help maintain the opening and fluid flow of the tract. The implant can be especially advantageous when the tissue tract is formed by means in which tissue is removed or removed from the tract, such as direct dissection, viscoelastic dissection or penetration through an incision. The implant can also extend into the suprachoroidal space to maintain the opening of the suprachoroidal space to aid fluid flow. With reference to Figure 5, an implant 24 may have features such as a flange 25 for anchoring an end in the anterior chamber or within the Schlemm's Canal. A typical implant will have a beveled tip 26 to aid in the advancement within the tract and fenestrations 24 to assist in the distribution of fluid flow. The implant may comprise an antifibrotic implant, space maintenance material, such as hyaluronic acid, tubular device, stent-like device or similar device to ensure that the drainage tube remains patent. The implant may comprise permanent or biodegradable materials. Antifibrotic agents such as metrotrexate, sirolimus, 5-fluorouracil and paclitaxel can be applied or released from a device or implant inside the tract. The implant can be in the form of microspheres, microparticles, microfibers, open or closed cell matrices, foams, gels, tube-like or stent-like devices, which can change their configuration in situ after implantation. An implant device placed in the tract may comprise any suitable implant material, including metals, such as stainless steel, titanium, titanium alloys, cobalt-chromium alloys; a polymeric material; ceramics, and carbon materials such as vitreous carbon. The implant may also have surface porosity to promote tissue ingrowth to provide mechanical fixation of the implant or mechanical characteristics to facilitate suture fixation. In addition, a tubular device can incorporate multiple fluid outlets or fenestrations along its length to provide improved flow characteristics. This is particularly important for an implant that resides in a tissue tract that connects the anterior chamber to both the suprachoroidal space and the Schlemm Canal since the tract will incorporate a flow path from the anterior chamber to both tissue passages to maximize the discharge of aqueous humor. An expandable stent-like implant can be placed inside the tract to enlarge the diameter of the tract or to provide fixation through mechanical means. The stent implant can be compressed and released into the tissue tract, or expanded in situ, for example, with a balloon attached to the microsurgical tool. The stent graft can also incorporate shape memory functionality to allow it to expand once placed in the tissue tract. In addition, the microsurgical tool can be provided with an outer sheath comprising the stent graft that is left behind after the core of the tool is removed. The stent graft can be placed in a tissue tract formed between the suprachoroidal space and the Schlemm Canal or alternatively can be placed in a tissue tract formed between the suprachoroidal space and the anterior chamber. The stent graft can be based on a pre-size in pre-surgical imaging or it can be designed to be cut to a size before or after implantation. The stent may also comprise a flange that can be placed in the Schlemm's Canal, the anterior chamber, or the suprachoroidal space to provide implant securing. In addition, the implant can also be made to partially restrict flow in the tract to provide a controlled amount of flow restriction that will be less than or equal to the maximum flow in the tract. This can be achieved, for example, by making implants with lumens of different sizes, or varying amounts of fenestrations in the tube wall. Implants with different flow values can be created and chosen for optimization of the aqueous flow by the surgeon. Also, the flow characteristics of an implant can be varied after the procedure in the examination of the patient's IOP. Various energy sources such as laser, RF or microwave light can be directed to a portion of the implant to dilate or contract discrete segments to control the flow. A photoreactive polymer or a pre-stressed polymer similar to thermal shrink tubing may be employed to perform this function. The procedure may also be performed at more than one site per eye as may be required to provide adequate drainage. In practice, the procedure can be performed in one or more sites, and the patient's IOP is monitored postoperatively. If further pressure reduction is required, then a subsequent procedure may be performed at another target site. Multiple tracts of tissue can be created in this way for drainage of aqueous humor. The tracts can all be created in a single operation by advancing the microsurgical tool and by operating it a plurality of times to form multiple tracts of tissue from the first passage to the second passage using a single surgical access site. The following examples are presented for the purpose of illustration and are not intended to limit the invention in any way.

Example 1 A corpseless human eye without a nucleus was used for this test. The eye was prepared by removing any excess tissue around the limbus and replacing lost fluid until the eye was firm to the touch. A rectangular sclerotic flange, approximately 5 mm wide by 4 mm long, is cut posteriorly from the limbus in order to expose the Schlemm Canal. A flexible microcannula prototype with an outer diameter of approximately 220 microns was used. The microcannula was manufactured with a communication element comprised of polyimide tubing 0.006 x 0.008 inches in diameter. Co-linear to the communication element was a stiffening member comprised of a stainless steel wire 0.001 inches in diameter and a plastic optical fiber 0.004 inches in diameter. A polyethylene terephthalate (PET) thermal shrink tubing was used to join the elements in a single composite microcannula. The plastic fiber optic is Incorporated to provide an illuminated beacon tip for the location. The beacon tip was illuminated using a battery operated red light laser diode source. The microcannula was inserted into the ostios of the Schlemm Canal and advanced along the Schlemm Canal and advanced along the canal. After advancing about 3 clock hours along the channel, the microcannula was advanced further into the suprachoroidal space, forming a tissue tract for aqueous humor flow. The beacon tip of the microcannula was easily seen on the outer surface, through the sclerotic walls through the procedure, helping the guide.

Ejeraplo 2 A corpseless human eye without core was prepared as in Example 1. Using a high resolution ultrasound imaging system developed by the applicant, a tissue imaging scan was performed to plan the access and route of placement of a shunt from the suprachoroidal space to the anterior chamber. A radial incision was made in the pars plana and extending through the sclera to expose the choroid. A microcannula was used (MicroFil, Word Precision Instruments, Sarasota, FL). The microcannula comprised a 34-gauge fused silica core tube lined with polyimide The microcannula was inserted into the surgical incision in a anterior direction and at a small angle with respect to the sclera surface. The microcannula was advanced until the distant tip penetrated the anterior chamber. The high resolution imaging with ultrasound confirmed the placement of the cannula in the suprachoroidal space and extending above the ciliary body and penetrating the anterior chamber in the anterior angle. The 15 mm distant from the cannula was then cut, remaining in place between the anterior chamber and the surgical site. Fluid flow was seen at the proximal end of the cannula. The proximal end was then placed in the suprachoroidal space and the incision was sealed with cyanoacrylate adhesive. An infusion set consisting of a high reservoir filled with phosphate buffered saline (PBS) connected to a 30 gauge hypodermic needle was used to impregnate the eye. The infusion pressure was adjusted to constant 10 mm Hg by adjusting the height of the PBS reservoir. The needle was inserted through the cornea in the anterior chamber and the eye was allowed to impregnate for 60 minutes to reach equilibrium. An injection of 0.1 ce of methylene blue was made in the anterior chamber. The eye was impregnated for another 4 hours. The perfusion was finished andthe eye was examined visually. The sclerotic tissues were stained with methylene blue in an area around the suprachoroidal tract, demonstrating flow in the anterior chamber to the suprachoroidal space. A rectangular surgical flange was created around the previous radial incision with margins of approximately 3 mm. The flange retracted and the tissues were observed. The internal sclerotic surface and the outer choroidal surface were stained uniformly with methylene blue demonstrating flow in the suprachoroidal space.

Ejeraplo 3 A test was performed to evaluate a tubular implant that connects the Schlemm Canal to the suprachoroidal space. A human corpse eye without a core was used and prepared as in Example 1. A radial incision was made in the superior-temporal limbal region, the incision extending from about 4 mm to the depth of the Schlemm Canal. The posterior end of the incision extended inward to expose the suprachoroidal space without cutting the choroid layer. The sclerotic stalk fibers but were left intact. A tubular implant comprised of polyimide tubing, 0.0044 inches inside diameter x 0.00050 inches outside diameter, was fabricated. The bypass pipe was divided to the half by a distance of 0.5 mm. The two halves of the tube were then folded back to create a "Tee" tab on the far end. A fold of approximately 30 ° was made in the body of the tube, 0.75 mm close to the division. The base length of the "Tee" was 2.5 mm. The distant end of the diverter was first placed in the SCS, then the far end was placed in the channel such that the "Tee" tabs were placed within the ostium of the cut, in order to stabilize the implant in situ. The surgical incision was sealed with cyanoacrylate adhesives. An infusion set consisting of a high reservoir filled with phosphate buffered saline (PBS), connected to a variable orifice flow meter and a 30 gauge hypodermic needle was used to impregnate and determine the aqueous discharge in the eye. The contralateral eye was prepared using a false surgical procedure identical to the implanted eye, but without the placement of the tubular implant. The infusion pressure was adjusted to 10 mm Hg constant by adjusting the height of the PBS reservoir. The perfusion was allowed to run for approximately 24 hours, at which time the aqueous discharge capacity of the test eye with the implant was greater than that of the control eye.

Ejeraplo 4 A test was performed as described in Example 3. After 24 hours of perfusion, methylene blue dye was injected into the anterior chamber of the test eye. After another 24 hour period, the methylene blue has been cleared from the anterior chamber and there is visible evidence of staining of the suprachoroidal space, demonstrating flow from the anterior chamber.

Example 5 A test was performed as described in Example 3. In this experiment, the dimensions of the tubular implant were increased. The dimensions of the implant were 0.0062 inches inside diameter x 0.0080 inches outside diameter. The constant pressure perfusion of 10 mm Hg was used. The perfusion was allowed to continue for 6 days and the aqueous discharge capacity of the test eye with the implant was greater than the control eye.

Example 6 A test was performed as described in Example 3. The flanged tubular implant was fabricated from Pebax polymer with a 72 Shore D durometer, and 0.006-inch inner diameter dimension 0.008. inches of outside diameter. The arms of the "Tee" are approximately 0.02 inches long and the base of the "Tee" was 0.2 inches long. The proximal end of the diverter was beveled and small penetrations or openings were made along the length of the base of the "Tee" for better distribution of the fluid flow. The implant is similar to that shown in Figure 5.

Claims

CLAIMS 1. Apparatus for forming a tissue tract from within a first passage of an eye that connects to a second passage in the eye, characterized in that it comprises an elongated tool with a proximal end and a distal end, the tool having a diameter outside in the range of about 50 to about 1000 microns. Apparatus according to claim 1, characterized in that the tool comprises a flexible microcannula. Apparatus according to claim 2, characterized in that the flexible microcannula is located close to the distal end. 4. Apparatus in accordance with the claim 1, characterized in that the tool comprises an outer sheath and an inner member. 5. Apparatus in accordance with the claim 4, characterized in that the outer sheath is flexible and the inner member has a greater bending stiffness than the outer sheath. 6. Apparatus in accordance with the claim 5, characterized in that the inner member can be removed and changed with another inner member during the use of the eye apparatus. 7. Apparatus according to claim 3, characterized in that the flexible microcannula comprises a rounded atraumatic distal term that forms the distal end of the tool. 8. Apparatus in accordance with the claim 1, characterized in that the flexible microcannula additionally comprises a lubricious outer surface coating. Apparatus according to claim 1, characterized in that the tool comprises a mechanical cutting tip at the distal end. Apparatus according to claim 1, characterized in that the tool has a capacity to direct tissue ablative energy from the distant end. Apparatus according to claim 10, characterized in that the energy comprises laser light, radiofrequency energy or thermal energy. Apparatus according to claim 1, characterized in that the distant tip is visible by the imaging to allow image guidance during tract formation. Apparatus according to claim 12, characterized in that the imaging comprises ultrasound or optical coherence topography. 14. Apparatus according to claim 1, characterized in that the distant tip comprises a visible optical beacon under direct observation through sclerotic tissues. 15. Apparatus in accordance with the claim 1, characterized in that it also comprises a space maintenance material or implant for placement within the tract. Apparatus according to claim 1, characterized in that the tool comprises a means for direct dissection, viscoelastic dissection or tissue penetration. Apparatus according to claim 15, characterized in that the space maintenance material comprises hyaluronic acid. 18. Apparatus according to claim 15, characterized in that the space maintenance material comprises an anti-fibrotic agent. 1 . Apparatus according to claim 18, characterized in that the anti-fibrotic agent comprises methotrexate, paclitaxel, 5-fluoro-uracil or sirolimus. Apparatus according to claim 15, characterized in that the space maintenance material comprises an anti-thrombotic agent. 21. Apparatus according to claim 20, characterized in that the anti-thrombotic agent comprises heparin or tissue plasminogen activator. 22. Apparatus according to claim 15, characterized in that it comprises a tube or endoprosthesis type device. 23. Apparatus according to claim 15, characterized in that the implant comprises stainless steel, titanium, titanium alloy with nickel, cobalt-chromium alloy, ceramic, carbon or polymeric material. 24. Apparatus according to claim 15, characterized in that the implant is capable of changing the configurations when it is distributed in the eye from the apparatus. 25. Implant for placement in a tract of tissue surgically formed in the eye between the suprachoroidal space and the Schlemm Canal, characterized in that the implant maintains the space of the tissue tract and provides a path for aqueous humor flow through the tract of tissue. 26. Implant for placement in a tract of tissue surgically formed between the suprachoroidal space and the anterior chamber, characterized in that the implant maintains the tract space of the tissue and provides a route for aqueous humor flow through the tissue tract. 27. Implant according to claim 25 or 26, characterized in that it comprises microspheres, microparticles, microfibers, open or closed cell matrices, foam, gel, a tubular device or a stent-like device. 28. An implant according to claim 25 or 26, characterized in that it comprises a suture, a flange, or a growth surface inward of the tissue to provide tissue fixation of the implant in the tract. 29. Implant according to claim 25 or 26, characterized in that it comprises stainless steel, titanium, titanium alloy, cobalt-chromium alloy, ceramic, carbon or polymeric material. 30. Implant according to claim 25 or 26, characterized in that it comprises a biodegradable or bioerodible material. 31. Implant in accordance with the claim 25 or 26, characterized in that it comprises an anti-fibrotic material. 32. Method for creating a fluid path for aqueous humor of an eye from a first passage of the eye comprising the Schlemm Canal to a second passage comprising the suprachoroidal space, the method is characterized in that it comprises: a) inserting a microsurgical tool from a surgical access site in the first passage; b) advancing the tool along the first passage to a desired site for the formation of a tissue tract for the fluid path; c) driving the tool to form the tissue tract from the first passage to the second passage; d) remove the tool, and e) close the surgical access site. 33. Method for creating a fluid path for aqueous humor of an eye from a first passage of the eye comprising the suprachoroidal space to a second selected passage of Schlemm's Canal or the anterior chamber, the method is characterized in that it comprises: a) insert a microsurgical tool from a surgical access site in the first passage; b) advancing the tool along the first passage to a desired site for the formation of a tissue tract for the fluid path; c) operate the tool to form the tract of tea from the first passage to the second passage; d) remove the tool, and e) close the surgical access site. 34. Method according to claim 32 or 33, characterized in that the base of the tool and the drive of the tool to form the tract are directed by imaging. 35. Method of compliance with the claim 32 or 33, characterized in that the tool comprises a flexible microsurface. 36. Method according to claim 32 or 33, characterized in that it also comprises placing a material for maintenance of space or implant within the tract. 37. Method according to claim 32 or 33, characterized in that the space maintenance material comprises hyaluronic acid. 38. Method of compliance with the claim 32 or 33, characterized in that the implant comprises a tube-like device or a stent-like device. 39. Implant according to claim 32 or 33, characterized in that the implant comprises a suture, a flange, or a growth surface inward of the tissue to provide tissue fixation of the implant in the tract. 40. Method according to claim 32 or 33, characterized in that the advance of the tool and the actuation of the tool are carried out plurality of times to form multiple tracts of tissue from the first passage to the second passage using a single surgical access site.